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MitraClip System for Heart Failure (COAPT Trial)
COAPT Trial Summary
This trial is testing the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation in Symptomatic Heart Failure Subjects. It is a randomized controlled trial with 610 subjects. A subset of patients will also be registered in a cardiopulmonary exercise sub-study.
COAPT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOAPT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COAPT Trial Design
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Who is running the clinical trial?
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- I have severe mitral regurgitation due to heart muscle issues, confirmed by recent heart scans.You have certain heart conditions that make it unsafe for you to participate in the study. These include high blood pressure in the lungs, specific types of heart muscle diseases, unstable heart function, or recent heart device implantation.I had a TAVR procedure within the last 30 days.I have been diagnosed with the most advanced stage of heart failure.My heart valve issue is due to heart muscle problems, not a damaged valve.My heart function test was done after my treatment was stable and any major changes.My heart failure markers were measured after my treatment was stable and any major changes.My heart's pumping chamber size is within normal limits on a recent echo test.My heart condition has been treated according to current standards.I've been hospitalized for heart failure in the last year or have high BNP/NT-proBNP levels.I am able to participate in the CPX study according to my doctor's assessment.I have a severe narrowing in my neck artery.I understand and agree to possibly receiving non-surgical treatment if placed in the Control group.I have a serious heart artery problem that hasn't been treated yet.My heart condition will be treated with medication, not surgery, as agreed by my medical team.I am 18 years old or older.Your heart's pumping ability, measured by a specific type of test, must be between 20% and 50%.I need home oxygen or take steroids daily for my COPD.I had a procedure to open blocked arteries in my heart within the last 30 days.I have some limitations on physical activity due to heart issues.I need surgery for a heart valve problem.I have not had carotid surgery or stenting in the last 30 days.I need surgery or a special procedure for my heart valve problem.The doctor thinks it is possible to access the heart through the veins in the leg for the procedure.If the main leaky valve in your heart can be fixed with a MitraClip, and if there is a smaller leaky valve, it must not cause significant problems.I have not had a heart bypass surgery in the last 30 days.Criterion: Your heart valve and overall health should not have certain issues that would prevent the MitraClip device from being implanted or working properly. These issues include: not enough mobile leaflet for the device, calcification in the grasping area, significant cleft in the grasping area, lack of chordal support, short leaflet mobility, unstable blood pressure, need for urgent or planned cardiac surgery, life expectancy less than 12 months due to non-heart conditions, severe disability, prior heart transplant or valve surgery, presence of heart masses or infections, allergic reactions to certain medications, pregnancy or planning to become pregnant soon, participating in another research study, or inability to give consent or follow study procedures.I have not had a stroke in the last 30 days.Your CK-MB blood test taken in the last 14 days is lower than the normal range for the local lab.
- Group 1: MitraClip System
- Group 2: Control Group
- Group 3: COAPT CAS Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are recruitment efforts for this research project still ongoing?
"According to clinicaltrials.gov, this medical trial has ceased recruitment of patients since its last edit on September 21st 2022. Fortunately, there are 787 additional studies that participants may join at the present moment."
Is this study available in multiple locations across North America?
"The clinical trial is accepting applications from 86 different sites including the University of Virginia in Charlottesville, St. Vincent Heart Center of Indiana in Indianapolis and Henry Ford Hospital in Detroit among many others."
What purpose is this research endeavor striving to fulfill?
"This clinical trial, which is expected to take 12 months in total, has Primary Effectiveness Endpoint as its primary outcome. Two secondary outcomes will also be assessed: the Six Minute Walk Test (6MWT Distance or 6MWD) and potential Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis). Additionally, Major Vascular Complications (COAPT CAS Study Analysis) will be tracked throughout the duration of this experiment."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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